MigrainePhase 4NCT00210509
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache
A Phase 4 study testing almotriptan malate in people with Migraine, run by Janssen-Ortho LLC.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- almotriptan malate
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine, with or without aura
- At least moderate pain with migraines
- Average of 2 to 6 migraines per month for past 3 months
- Duration of headache pain at least 4 hours
- Able to tell the difference between a migraine and a tension headache
- If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening
- In generally good health
- If female, using birth control
Who cannot join
- Routinely experience other type of headache that might seem like a migraine headache
- An average of 15 or more headache days per month in the past 6 months
- Migraines began after age 50
- Taking > 1 medicine for preventing migraines
- Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days
- Use of non-drug treatment for migraine in past 14 days unless have used this treatment for > 14 days and plan to continue throughout study
Show all 16Show fewer
- Overuse of medications that treat pain or nausea
- Migraine aura without headache
- Hemiplegic or basilar migraines
- Usually have vomiting with headache
- Headaches that usually occur upon waking
- Significant unstable medical disease
- Abnormal liver, kidney, blood, or ECG laboratory or test results
- Abusing drugs or alcohol
- History of a significant mental disorder
- Pregnant or breast-feeding
About this study
Official title: AXERT® Early miGraine Intervention Study (AEGIS): Efficacy and Safety of Almotriptan Malate (AXERT®) Versus Placebo for the Acute Treatment of Migraine Headache
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.
Read the detailed description
Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of adult patients with a diagnosis of migraine headache, with or without aura. Patients will be randomized (like with the toss of a coin) to receive almotriptan malate (AXERT®) or placebo for the treatment of 3 consecutive qualifying migraine headaches. After screening, patients will leave the study center with blinded study medication and an electronic subject diary (Personal Digital Assistant [PDA]). Patients will self-dose with study medication as soon as headache pain of any intensity begins (that resembles their usual migraine), but no later than 1 hour after headache pain begins. Patients will use their PDAs to record assessments such as pain intensity, symptom severity and ability to function as related to the headaches. The primary hypothesis of this study is that the percentage of patients who are pain free two hours after taking study drug at the earliest onset of headache pain is greater in the almotriptan malate (AXERT®) 12.5mg group than in the placebo group and almotriptan malate (AXERT®) is generally well-tolerated.
Almotriptan malate (AXERT®) 12.5 milligrams or placebo tablets, one by mouth at the beginning of migraine pain (within 1 hour) for 3 consecutive migraine headaches
- Conditions
- Migraine
- Being tested
- almotriptan malate
- Keywords
- aura, Migraine, pain, headache
- Medical subject headings
- Migraine Disorders, Epilepsy, Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
almotriptan malateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: pain free at 2 hours (defined as a decrease from severe, moderate or mild to no pain) without the use of supplemental pain medication and/or antiemetic medication up to the 2 hour timepoint
Secondary outcomes (1)
Effectiveness: time to pain free post-dosing; timed assessments to achieve pain relief at 0.5, 1, 2, 4 and 24 hours post-dosing; consistency of response; migraine-associated symptoms; migraine-associated vomiting; change in functional disability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Janssen Ortho LLC Clinical Trial, Study director, Janssen-Ortho LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210509
- Sponsor's protocol ID
- CR004714
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
Publications
Mathew NT, Finlayson G, Smith TR, Cady RK, Adelman J, Mao L, Wright P, Greenberg SJ; AEGIS Investigator Study Group. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Headache. 2007 Feb;47(2):189-98. doi: 10.1111/j.1526-4610.2006.00686.x.
PubMed 17300358
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXERT® Early miGraine Intervention Study (AEGIS): Efficacy and Safety of Almotriptan Malate (AXERT®) Versus Placebo for the Acute Treatment of Migraine Headache
- ClinicalTrials.gov ID
- NCT00210509
- Acronym / sponsor ID
- CR004714
- Conditions
- Migraine
- Keywords
- aura, Migraine, pain, headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Janssen-Ortho LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Nov 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.
Detailed description
Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of adult patients with a diagnosis of migraine headache, with or without aura. Patients will be randomized (like with the toss of a coin) to receive almotriptan malate (AXERT®) or placebo for the treatment of 3 consecutive qualifying migraine headaches. After screening, patients will leave the study center with blinded study medication and an electronic subject diary (Personal Digital Assistant [PDA]). Patients will self-dose with study medication as soon as headache pain of any intensity begins (that resembles their usual migraine), but no later than 1 hour after headache pain begins. Patients will use their PDAs to record assessments such as pain intensity, symptom severity and ability to function as related to the headaches. The primary hypothesis of this study is that the percentage of patients who are pain free two hours after taking study drug at the earliest onset of headache pain is greater in the almotriptan malate (AXERT®) 12.5mg group than in the placebo group and almotriptan malate (AXERT®) is generally well-tolerated.
Almotriptan malate (AXERT®) 12.5 milligrams or placebo tablets, one by mouth at the beginning of migraine pain (within 1 hour) for 3 consecutive migraine headaches
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of migraine, with or without aura
- At least moderate pain with migraines
- Average of 2 to 6 migraines per month for past 3 months
- Duration of headache pain at least 4 hours
- Able to tell the difference between a migraine and a tension headache
Key exclusion criteria (16 listed)
- Routinely experience other type of headache that might seem like a migraine headache
- An average of 15 or more headache days per month in the past 6 months
- Migraines began after age 50
- Taking > 1 medicine for preventing migraines
- Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| almotriptan malate | Drug | – |
Primary outcome
Effectiveness: pain free at 2 hours (defined as a decrease from severe, moderate or mild to no pain) without the use of supplemental pain medication and/or antiemetic medication up to the 2 hour timepoint
1 secondary outcome
Effectiveness: time to pain free post-dosing; timed assessments to achieve pain relief at 0.5, 1, 2, 4 and 24 hours post-dosing; consistency of response; migraine-associated symptoms; migraine-associated vomiting; change in functional disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Results publication: PubMed 17300358Mathew NT, Finlayson G, Smith TR, Cady RK, Adelman J, Mao L, Wright P, Greenberg SJ; AEGIS Investigator Study Group. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Headache. 2007 Feb;47(2):189-98. doi: 10.1111/j.1526-4610.2006.00686.x.
- AXERT Early Migraine Intervention Study (AEGIS)Link provided by the sponsor.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Ortho LLC Clinical Trial study director
Janssen-Ortho LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing almotriptan malate in people with Migraine, run by Janssen-Ortho LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: pain free at 2 hours (defined as a decrease from severe, moderate or mild to no pain) without the use of supplemental pain medication and/or antiemetic medication up to the 2 hour timepoint. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.